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NCT06774131 · ClinicalTrials.gov registry record · Phase 3
A Phase 3 Single-arm Study of UGN-104 for the Treatment of Low-grade Upper Tract Urothelial Cancer
A Phase 3 study of Urothelial Carcinoma and Upper Urinary Tract Urothelial Carcinoma, sponsored by UroGen Pharma.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 70
- Enrollment target
- 20
- Study locations
NCT06774131 is a Phase 3 study of Urothelial Carcinoma and Upper Urinary Tract Urothelial Carcinoma that is actively recruiting participants, run by UroGen Pharma. The registered enrollment target is 70 participants, below the 238-participant average among 85 other Urothelial Carcinoma trials with a reported enrollment target (71% lower). The trial reports 20 study locations across 12 states.
The verdict
NCT06774131, a Phase 3 study of Urothelial Carcinoma and Upper Urinary Tract Urothelial Carcinoma, is actively recruiting participants, sponsored by UroGen Pharma.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 70 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will evaluate the efficacy and safety of UGN-104, a new formulation of UGN-101 (approved in the United States and Israel as JELMYTO \[mitomycin\] for pyelocalyceal solution), instilled in the upper urinary tract (UUT) of patients with low-grade upper tract urothelial cancer (LG-UTUC).
Conditions Studied
Interventions
- DRUG UGN-104
Study Locations (20)
Florida
- BioResearch Partners Aventura - Aventura
- UF Health Cancer Center University of Florida - Gainesville
- BioResearch Partners Hialeah - Hialeah
South Carolina
- Medical University of South Carolina - Charleston
- Carolina Urologic Research Center, LLC - Myrtle Beach
- Low county Urology Clinics - North Charleston
Texas
- Amarillo Urology Research - Amarillo
- UPNT Research Institute, LLC - Arlington
- Texas Urology Specialists-Austin - Austin
California
- Michael G Oefelein Clinical Trials - Bakersfield
- University of California, Irvine - Orange
Other
- MHAT Haskovo AD - Haskovo
- University Multiprofile Hospital for Active Treatment and Emergency Medicine "N.I. Pirogov," Sofia, Clinic of Urology - Sofia
Alabama
- Urology Centers of Alabama - Homewood
Arizona
- Arizona State Urological Research Institute, LLC ("ASURI") - Chandler
Iowa
- Urology Center of Iowa Research - Clive
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2025-08-06 |
| Est. Completion | 2027-10 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06774131
The ClinicalTrials.gov registry entry for NCT06774131 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 238-participant average among 85 other Urothelial Carcinoma trials with a reported enrollment target (71% lower). The listed sponsor is UroGen Pharma, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Urothelial Carcinoma appearing as the primary indexed condition, and to 1 intervention - of which UGN-104 is the first listed.
NCT06774131 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Florida, South Carolina, Texas.
Frequently Asked Questions
What is clinical trial NCT06774131 about?
NCT06774131 is a clinical study titled "A Phase 3 Single-arm Study of UGN-104 for the Treatment of Low-grade Upper Tract Urothelial Cancer". This study will evaluate the efficacy and safety of UGN-104, a new formulation of UGN-101 (approved in the United States and Israel as JELMYTO \[mitomycin\] for pyelocalyceal solution), instilled in the upper urinary tract (UUT) of patients with low-grade upper tract urothelial cancer (LG-UTUC).
What is the current status of trial NCT06774131?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 70 participants. The study started on 2025-08-06. Estimated completion is 2027-10.
What conditions does trial NCT06774131 study?
This clinical trial studies the following conditions: Urothelial Carcinoma, Upper Urinary Tract Urothelial Carcinoma.
What interventions are being tested in trial NCT06774131?
The interventions under investigation include: UGN-104 (DRUG).
Who is sponsoring clinical trial NCT06774131?
This trial is sponsored by UroGen Pharma, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06774131 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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